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Sunday, September 26, 2021

Pfizer to submit data on children's vaccines to FDA 'pretty soon'--CEO

 Pfizer CEO Albert Bourla said on Sunday that his company would begin moving forward with efforts to get children eligible for the company's COVID-19 vaccine "pretty soon."

"I think we are going to submit this data pretty soon. It's a question of days not weeks," Bourla said on ABC's "This Week." 

Bourla noted that the Food and Drug Administration (FDA) would review the data after it is submitted and make the official decisions about approval.

Bourla said Pfizer would be ready to manufacture more doses for children if needed. He added that children ages 5 to 11 would receive about one-third of the dose adults receive. 

Pfizer announced on Sept. 20 that research showed its vaccine was safe and effective for children ages 5 to 11.

"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine," Bourla said at the time of that announcement. "We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children." 

https://thehill.com/homenews/sunday-talk-shows/573987-pfizer-to-submit-data-on-childrens-vaccines-to-fda-pretty-soon-ceo

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